Home NDC 0603-6160-32 Trazodone Hydrochloride
Product NDC 0603-6160
Requested package NDC 0603-6160-32
11-digit product format 006036160
Labeler code 0603
Product ID 0603-6160_33d705b2-795f-4fb8-96f2-96d48e6de326
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trazodone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Par Pharmaceutical
Application ANDA072192
Marketing category ANDA
Marketing start 2010-05-30
Marketing end 2021-06-30
Substance TRAZODONE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Serotonin Reuptake Inhibitor [EPC]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A072192-001 TRAZODONE HYDROCHLORIDE TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A072192-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A072192-001 TRAZODONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1989-02-02 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRAZODONE HYDROCHLORIDE ACTIVE INGREDIENT 6E8ZO8LRNM TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 TRAZODONE ACTIVE MOIETY YBK48BXK30 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 POVIDONES INACTIVE INGREDIENT FZ989GH94E TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [QUALITEST PHARMACEUTICALS] 14 TRAZODONE HYDROCHLORIDE ACTIVE INGREDIENT 6E8ZO8LRNM TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 Trazodone Hydrochloride ACTIVE INGREDIENT 6E8ZO8LRNM TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 trazodone ACTIVE MOIETY YBK48BXK30 TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 TRAZODONE ACTIVE MOIETY YBK48BXK30 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 hypromellose INACTIVE INGREDIENT 3NXW29V3WO TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 polydextrose INACTIVE INGREDIENT VH2XOU12IE TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 POLYDEXTROSE INACTIVE INGREDIENT VH2XOU12IE TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 povidone INACTIVE INGREDIENT FZ989GH94E TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 POVIDONES INACTIVE INGREDIENT FZ989GH94E TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRAZODONE HYDROCHLORIDE TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TRAZODONE HYDROCHLORIDE TABLET [CONTRACT PHARMACY SERVICES-PA] 1
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0603-6160-32 00603616032 1000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0603-6160-32) 2010-05-30 2021-06-30 No No Current